Bipolar DisorderNCT00472615
Menstrual Effects On Mood Symptoms in Bipolar Disorder
An observational study of Bipolar Disorder, run by University of Pittsburgh at 2 sites in United States.
Trial summary
Background and Rationale for Study: Estrogen and progesterone are female hormones that regulate the menstrual cycle and likely serve an important role in the regulation of mood. Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild dysphoria and physical discomfort that begin… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Community sample and outpatient psychiatric offices
Who may be able to join
- Ages 18-45;
- Bipolar Disorder (BD) I or II (DSM-IV criteria) must agrees to communication between PI and Psychiatrist;
- Healthy Control without Past or Current Major Depression, Psychotic Disorder, premenstrual syndrome or Premenstrual Dysphoric Disorder;
- 25-31day menstrual cycles;
- Minimum 6 menstrual cycles per year
Who cannot join
- Current DSM-IV Criteria Alcohol or Substance Abuse/Dependence;
- Pregnancy;
- Chronic Anovulation (<4 menstrual cycles/yr);
- Menopause (< 1menses in 1yr);
- Active thyroid disease;
- Hormonal Contraception
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Magee Womens Hospital, UPMC
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh, School of Medicine, Department of Psychiatry
Pittsburgh, Pennsylvania, 15213
About this study
Background and Rationale for Study: Estrogen and progesterone are female hormones that regulate the menstrual cycle and likely serve an important role in the regulation of mood. Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild dysphoria and physical discomfort that begin 1-2weeks pre-menses, and resolve by 2-3 days post-onset of menses. Up to 66% of women with bipolar disorder (BD) describe premenstrual mood changes that range from mild symptoms to severe worsening that require hospitalization. Therefore, the hormonal shifts of the menstrual cycle likely influence bipolar symptoms, but confirmatory research is lacking.
Study questions: The primary aims and hypotheses are to characterize bipolar mood symptoms throughout the menstrual cycle and to determine if women with BD have: 1) a) increased severity and persistence of depression and mania symptoms in the late luteal (premenstrual) vs early follicular phase, b) larger change in mood symptoms from the late luteal (premenstrual) to the early follicular phase, compared to healthy women, 2) more relapses, in the late luteal compared to the early follicular phase. The secondary aims are to determine: 1) frequency and severity of premenstrual dysphoric disorder (PMDD) type symptoms in bipolar women; 2) association between bipolar mood variability and a) menstrual phase, b) ovulatory vs anovulatory cycles, c) antimanic drug treatment.
Read the detailed description
Study Design: Women with BD (15 depressed, 15 euthymic), and 15 healthy women will enter the study. Over 3-months, subjects undergo monthly visits to assess mood and function, at the follicular and luteal phases. Ovulation is confirmed with: 1) urine dipstick tests to detect ovulation (LH surge) days8-14 from the onset of menses; 2) serum progesterone levels 7-days post-ovulation (LH surge). Subjects record their mood and physical symptoms on the daily self-report LifeChart and the Daily Rating Form.
Study Population: Women with Bipolar I or II Disorder, between ages 18-45. Primary Outcomes Measures: 1) a) mood severity - scores on the Structured Interview Guide for the Hamilton Depression Scale (SIGHADS) for depression, Mania Rating Scale (MRS) for mania/hypomania, and LifeChart mood ratings depression and mania/hypomania, for the late luteal and early follicular phases; b) persistence of symptoms - proportion of days with mild/moderate/severe depression or mania/hypomania. 2) Relapses - # bipolar episodes.
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Menstrual Cycle, Depression, Mania or Hypomania, Predictor
- Medical subject headings
- Bipolar Disorder, Depression, Mania
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startAug 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Dorothy K Sit, M.D., Principal investigator, University of Pittsburgh, School of Medicine, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472615
- Sponsor's protocol ID
- M01RR000056
- Other IDs
- CMRF of the UPMC Health System
- Status last verified
- Feb 2009
- First submitted
- 10 May 2007
- Last updated
- 26 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menstrual Effects On Mood Symptoms in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00472615
- Acronym / sponsor ID
- M01RR000056
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Menstrual Cycle, Depression, Mania or Hypomania, Predictor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 14 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Rationale for Study: Estrogen and progesterone are female hormones that regulate the menstrual cycle and likely serve an important role in the regulation of mood. Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild dysphoria and physical discomfort that begin 1-2weeks pre-menses, and resolve by 2-3 days post-onset of menses. Up to 66% of women with bipolar disorder (BD) describe premenstrual mood changes that range from mild symptoms to severe worsening that require hospitalization. Therefore, the hormonal shifts of the menstrual cycle likely influence bipolar symptoms, but confirmatory research is lacking.
Study questions: The primary aims and hypotheses are to characterize bipolar mood symptoms throughout the menstrual cycle and to determine if women with BD have: 1) a) increased severity and persistence of depression and mania symptoms in the late luteal (premenstrual) vs early follicular phase, b) larger change in mood symptoms from the late luteal (premenstrual) to the early follicular phase, compared to healthy women, 2) more relapses, in the late luteal compared to the early follicular phase. The secondary aims are to determine: 1) frequency and severity of premenstrual dysphoric disorder (PMDD) type symptoms in bipolar women; 2) association between bipolar mood variability and a) menstrual phase, b) ovulatory vs anovulatory cycles, c) antimanic drug treatment.
Detailed description
Study Design: Women with BD (15 depressed, 15 euthymic), and 15 healthy women will enter the study. Over 3-months, subjects undergo monthly visits to assess mood and function, at the follicular and luteal phases. Ovulation is confirmed with: 1) urine dipstick tests to detect ovulation (LH surge) days8-14 from the onset of menses; 2) serum progesterone levels 7-days post-ovulation (LH surge). Subjects record their mood and physical symptoms on the daily self-report LifeChart and the Daily Rating Form.
Study Population: Women with Bipolar I or II Disorder, between ages 18-45. Primary Outcomes Measures: 1) a) mood severity - scores on the Structured Interview Guide for the Hamilton Depression Scale (SIGHADS) for depression, Mania Rating Scale (MRS) for mania/hypomania, and LifeChart mood ratings depression and mania/hypomania, for the late luteal and early follicular phases; b) persistence of symptoms - proportion of days with mild/moderate/severe depression or mania/hypomania. 2) Relapses - # bipolar episodes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample and outpatient psychiatric offices
Key inclusion criteria (5 listed)
- Ages 18-45;
- Bipolar Disorder (BD) I or II (DSM-IV criteria) must agrees to communication between PI and Psychiatrist;
- Healthy Control without Past or Current Major Depression, Psychotic Disorder, premenstrual syndrome or Premenstrual Dysphoric Disorder;
- 25-31day menstrual cycles;
- Minimum 6 menstrual cycles per year
Key exclusion criteria (6 listed)
- Current DSM-IV Criteria Alcohol or Substance Abuse/Dependence;
- Pregnancy;
- Chronic Anovulation (<4 menstrual cycles/yr);
- Menopause (< 1menses in 1yr);
- Active thyroid disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2009.
- Western Psychiatric Institute and Clinic - Women's Behavioral HealthCARE Research StudiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorothy K Sit, M.D. principal investigator
University of Pittsburgh, School of Medicine, Department of Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2009.